We work exclusively on orphan drugs and advanced therapies. We advise, plan, develop, write, review, and submit regulatory dossiers.
Regulatory specialists with a purpose:
We are senior regulatory experts offering strategic and operational support to global biotech companies developing orphan drugs and advanced therapies. With more than 300 years of combined experience, our team of regulatory pioneers possesses comprehensive knowledge of orphan drugs, advanced therapies, and strategic global requirements. Our deep expertise is derived from facilitating hundreds of global agency interactions and successful regulatory programs.
We are your dedicated regulatory partner:
We partner with clients who, like us, are driven by a passion and purpose to bring rare disease therapies to patients. Designing a clinical trial and an accompanying regulatory pathway requires critical, creative, and reliable thinking.
We don’t see regulations as a hurdle. We see them as the runway to patient access and marketing.
We will prioritize, define, and accomplish regulatory milestones by collaborating with regulators and driving integrated CMC, nonclinical, clinical, and regulatory strategies. We provide a broad range of services and expertise to accommodate any regulatory need.
Collective expertise and insights across our entire practice:
When you work with us, you'll be partnered with a dedicated team that will focus on your project. Your team will work collaboratively, with access to collective expertise and insights from our entire practice. This ensures that every aspect of your project benefits from the broad knowledge and experience of our entire organization, offering a comprehensive, well-rounded approach to your needs
Visit our website to hear what our clients are saying about us.
Company Details
- Employees
- 9
- Founded
- -
- Address
- 8 Market Pl, Baltimore,maryland 21202,united States
- Phone
- 443-414-3178
- co****@****ing.com
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Website
- raremoonconsulting.com
- Keywords
- Orphan Product Development, IND Execution & Publishing, Rare Disease, Regulatory Affairs, IND Gap Analysis, Project Management, Nonclinical Support, Risk Assessment and Product Feasibility Checks, ADME & Toxicology, BioAnalytical Support and Analysis, Advanced therapy medicinal products (ATMPs).
- HQ
- Baltimore, Maryland
- Competitors
- Amarex Clinical Research, LLC, an NSF company, Adjuvant Partners, Alhena Consult - Regulatory Affairs & Drug Development, Association for Accessible Medicines, North Carolina Biotechnology Center (NCBiotech), FDA, US Pharmacopeia, BioPoint Inc., Vitale Health Economics and Policy, Tenaya Therapeutics.
Raremoon | Regulatory Affairs Questions
Raremoon | Regulatory Affairs's helpline number is 443-414-3178
Raremoon | Regulatory Affairs's website is raremoonconsulting.com
Raremoon | Regulatory Affairs's LinkedIn profile is https://www.linkedin.com/company/raremoon-consulting
Raremoon | Regulatory Affairs has
9 employees.
View email and phone details for 9
employees at Raremoon | Regulatory Affairs.
Raremoon | Regulatory Affairs's industry is
Biotechnology Research
Raremoon | Regulatory Affairs's top competitors are
Amarex Clinical Research, Llc, An Nsf Company,
Adjuvant Partners,
Alhena Consult - Regulatory Affairs & Drug Development,
Association For Accessible Medicines,
North Carolina Biotechnology Center (Ncbiotech),
Fda,
Us Pharmacopeia,
Biopoint Inc.,
Vitale Health Economics And Policy,
Tenaya Therapeutics.
Raremoon | Regulatory Affairs's support email address is contactus@raremoonconsulting.com
Raremoon | Regulatory Affairs's categories are Biotechnology Research
Raremoon | Regulatory Affairs's founding year is 2016
